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SAFE-Per CD: Perampanel in Cervical Dystonia
NCT02131467Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2017
- Primary completion
- Feb 2020
- Countries
- 2
- Sponsor
- University Health Network
- Modality
- Classical Binding Small Molecules
- Drugs
- perampanel
- Conditions
- cervical dystonia (CD)
01
Overview
Phase 2, open-label, single-arm trial of perampanel in cervical dystonia (CD), sponsored by University Health Network. Primary endpoint: Number of subjects able to remain on study drug for minimum of 4 weeks at 12 weeks. Started Sep 2017; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Perampanel
Perampanel oral tablets, titrated to effect/tolerance.
03
Who it enrols
Adults 18-65 with primary cervical dystonia, either untreated with botulinum toxin or non-responsive/stable. Excludes secondary dystonia, cognitive impairment, active psychosis/depression, and significant renal/liver dysfunction.
04
Endpoints
Primary
Number of subjects able to remain on study drug for minimum of 4 weeks
Secondary
Cumulative number of new adverse events
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